NCT05179707

Brief Summary

Before prostate puncture, the patient's serum was collected for PHI detection, and multi-parameter MRI was performed to obtain the PI-RADS score. The sensitivity and specificity of PHI combined with PI-RADS score in the diagnosis of clinically significant prostate cancer were explored.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
936

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 5, 2022

Completed
27 days until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

October 12, 2022

Status Verified

January 1, 2022

Enrollment Period

1.7 years

First QC Date

December 1, 2021

Last Update Submit

October 7, 2022

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (3)

  • Prostate Health Index

    PHI is a simple, FDA-approved blood test that helps determine the probability of detecting prostate cancer with a biopsy. This test uses an algorithm to assess total PSA, free PSA, and p2PSA,

    1 year

  • PI-RADS score

    In PI-RADS, based on the comprehensive manifestations of prostate T2WI, DWI and DCE, a scoring method is given for the possibility of clinically significant prostate cancer. Specifically: 1 point: very low, extremely unlikely to exist; 2 points: low, impossible to exist; 3 points: moderate, suspicious existence; 4 points: high, may exist; 5 points: very high, extremely likely to exist.

    1 year

  • Prostate biospy pathology

    The pathological results of prostate puncture are used as the gold standard for the diagnosis of prostate cancer, indicating whether the patient is really suffering from prostate cancer

    1 year

Eligibility Criteria

Age50 Years - 80 Years
Sexmale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Male patients aged 50 to 80 years with indications for prostate puncture

You may qualify if:

  • Patients with suspected prostate cancer
  • Patients can perform standardized prostate biopsy

You may not qualify if:

  • Have a history of prostate cancer
  • Use of drugs that affect PSA before blood sampling

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qilu hospital

Jinan, Shandong, 276600, China

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Central Study Contacts

Shouzhen Chen, Dr.

CONTACT

18560089085chensz@mail.sdu.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2021

First Posted

January 5, 2022

Study Start

February 1, 2022

Primary Completion

October 1, 2023

Study Completion

October 1, 2023

Last Updated

October 12, 2022

Record last verified: 2022-01

Locations

CN(1)